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Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets

NCT06214130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-01-23

No results posted yet for this study

Summary

Comparative bioavailability of valproate from Orfiril long 500 mg prolonged-release mini-tablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers under fasting conditions.

Conditions

  • Multiple Drug Use

Interventions

DRUG

Sodium valproate 500 MG

oral intake

DRUG

Valproic Acid 500 MG

oral intake

Sponsors & Collaborators

  • BioPharma Services Inc.

    collaborator INDUSTRY

  • Desitin Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Janice Faulknor, MD · BioPharma Services Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2023-11-06
Completion
2023-11-18

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214130 on ClinicalTrials.gov